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Clinical Trials/ISRCTN78768405
ISRCTN78768405
Completed
Not Applicable

Efficacy and safety of rectal artesunate in paediatric patients - a randomised controlled study (Ghana and Tanzania)

ICEF/UNDP/World Bank/WHO - Special Programme for Research and Training in Tropical Diseases (TDR)0 sites246 target enrollmentJune 7, 2005

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Not specified
Sponsor
ICEF/UNDP/World Bank/WHO - Special Programme for Research and Training in Tropical Diseases (TDR)
Enrollment
246
Status
Completed
Last Updated
11 years ago

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
June 7, 2005
End Date
TBD
Last Updated
11 years ago
Study Type
Interventional
Sex
All

Investigators

Sponsor
ICEF/UNDP/World Bank/WHO - Special Programme for Research and Training in Tropical Diseases (TDR)

Eligibility Criteria

Inclusion Criteria

  • 1\. Aged 3 to 24 months
  • 2\. Suspected malaria with no other obvious cause of illness
  • 3\. P. falciparum asexual parasitaemia greater than \+\+ (5 \- 10 parasites/High Power Field \[HPF])
  • 4\. Unable to eat, suck or drink, or repeatedly vomiting (more than three episodes over past 24 hours); or prostrate (unable to sit or stand if previously able to do so)
  • 5\. History of convulsions over the preceding 24 hours or impaired consciousness (Blantyre Coma Score less than five)
  • 6\. Parent/guardian informed consent

Exclusion Criteria

  • 1\. Ability to tolerate oral intake
  • 2\. Acute diarrhoea defined as the presence of more than three episodes of watery stools in the preceding 24 hours
  • 3\. History of allergy to artemisinin compounds and/or quinine

Outcomes

Primary Outcomes

Not specified

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